UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052694 |
|---|---|
| Receipt number | R000059857 |
| Scientific Title | Evaluation of the Effects of Resistance Training on Adult Men Consuming Acerola Puree: Focusing on Muscle Mass, Strength, Stress, and Fatigue |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2023/11/04 00:26:09 |
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Basic information
Public title
Evaluation of the Effects of Resistance Training on Adult Men Consuming Acerola Puree: Focusing on Muscle Mass, Strength, Stress, and Fatigue
Acronym
Evaluation of the Effects of Resistance Training on Adult Men Consuming Acerola Puree: Focusing on Muscle Mass, Strength, Stress, and Fatigue
Scientific Title
Evaluation of the Effects of Resistance Training on Adult Men Consuming Acerola Puree: Focusing on Muscle Mass, Strength, Stress, and Fatigue
Scientific Title:Acronym
Evaluation of the Effects of Resistance Training on Adult Men Consuming Acerola Puree: Focusing on Muscle Mass, Strength, Stress, and Fatigue
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects on muscle mass, strength, stress, and fatigue in adult male subjects who perform resistance training three times a week and consume acerola puree
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass
Key secondary outcomes
Physical Function
Stress Biomarkers
Fatigue level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Acerola puree ingestion with resistance training group
Interventions/Control_2
Resistance training group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Those who are between 20 and 64 years old at the time of obtaining the consent form.
2. Those who have no allergy or rejection to acerola puree
3. Those who are able to cease food intake that could affect the outcome of this study (those who do not routinely consume nutritional supplements, dietary supplements, protein, etc.)
4. Those who have little exercise habits or have not trained professionally for at least the past year
. Those with no illnesses (depression, sleep disorders, etc.) or related medications that could affect the outcomes of this study
6. No physical dysfunction or severe joint pain (knee pain, back pain, etc.)
7. Fully understand the content of this study and voluntarily participate in it (consent).
Even if all of the above selection policies are met, if the principal investigator determines that the subject is not suitable for this study, the subject will not be allowed to participate in the study.
Key exclusion criteria
no
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | AOKI |
| Middle name | |
| Last name | HITOSHI |
Organization
NICHIREI FOODS INC.
Division name
Food Research Institute Research & Development Group
Zip code
261-0002
Address
9, Shinminato, Mihama-ku, Chiba-shi, Chiba
TEL
080-6759-9277
aokih@nichirei.co.jp
Public contact
Name of contact person
| 1st name | Haramoto |
| Middle name | |
| Last name | Noriaki |
Organization
NICHIREI FOODS INC.
Division name
Food Research Institute Research & Development Group
Zip code
261-0002
Address
9 Shinko, Mihama-ku, Chiba-shi, Chiba
TEL
090-3518-4107
Homepage URL
haramoton@nichirei.co.jp
Sponsor or person
Institute
NICHIREI FOODS INC.
Institute
Department
Personal name
Funding Source
Organization
NICHIREI FOODS INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NICHIREI FOODS INC.
Address
9 Shinko, Mihama-ku, Chiba-shi, Chiba
Tel
090-3518-4107
haramoton@nichirei.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059857
